Weill Cornell Medicine Events

TWIST - Inspection Findings Related to the Informed Consent Procedure: Lessons Learned

Informed consent irregularities remain one of the leading findings in FDA and EMA inspections. Join us as we examine real examples of FDA warning letters addressing informed consent inspection findings and discuss appropriate corrective and preventative actions (CAPAs), devising solutions to avoid common informed consent pitfalls and ultimately avoid inspection findings. Attendees are encouraged to share their experiences as we discuss methods and tools to aid in compliance with appropriate techniques for the informed consent process.  Tools will be provided to assist with compliance.

Learning Objectives

  • Critically assess the number of current major and critical inspection findings related to the ICF procedure.
  • Prevent major and critical inspections findings related to informed consent procedure.
  • Take proper corrective actions to resolve major and critical inspection findings related to the informed consent procedure.

Tuesday, January 23 at 11:00am to 12:00pm

Uris Auditorium
1300 York Ave., New York NY 10065